Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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17 May 2016 |
Main ID: |
NCT02763800 |
Date of registration:
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04/05/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202
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Scientific title:
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Double-Blind, Randomised, Placebo-Controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202, in Young Healthy Volunteers |
Date of first enrolment:
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September 2000 |
Target sample size:
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33 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02763800 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult males aged 18-35 years, with a body mass index (BMI) of 19-28 kg/m2.
- Subjects who were healthy as determined by pre-study medical history, physical
examination and 12-lead ECG.
- Subjects who had clinical laboratory tests acceptable to the investigator.
- Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.
- Subjects who were negative for drugs of abuse and alcohol tests at screening and
admission.
- Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per
day.
- Subjects who were able and willing to give written informed consent.
Exclusion Criteria:
- Subjects who did not conform to the above inclusion criteria.
- Subjects who had a clinically relevant history or presence of respiratory,
gastrointestinal, renal, hepatic, haematological, lymphatic, neurological,
cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological,
dermatological, connective tissue diseases or disorders.
- Subjects who had a clinically relevant surgical history.
- Subjects who had a clinically relevant family history.
- Subjects who had a history of relevant atopy.
- Subjects who had a history of relevant drug hypersensitivity.
- Subjects who had a history of alcoholism.
- Subjects who had a history of drug abuse.
- Subjects who consumed more than 28 units of alcohol a week.
- Subjects who had a significant infection or known inflammatory process on screening
and/or admission.
- Subjects who had acute gastrointestinal symptoms at the time of screening and/or
admission (e.g. nausea, vomiting, diarrhoea, heartburn).
- Subjects who had an acute infection such as influenza at the time of screening and/or
admission.
- Subjects who had used prescription drugs within 4 weeks of first dosing.
- Subjects who had used over the counter medication, excluding routine vitamins but
including mega dose vitamin therapy, within one week of first dosing.
- Subjects who had used any investigational drug and/or participated in any clinical
trial within 3 months of their first admission to this study.
- Subjects who had previously received BIA 3-202.
- Subjects who had donated and/or received any blood or blood products within 3 months
prior to screening.
- Subjects who were vegetarians, vegans and/or had medical dietary restrictions.
- Subjects who could not communicate reliably with the investigator.
- Subjects who were unlikely to co-operate with the requirements of the study.
- Subjects who were unwilling or unable to give written informed consent.
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Placebo
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Drug: BIA 3-202
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Primary Outcome(s)
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Area under the plasma concentration time curve extrapolated to infinity (AUC0-8) - D1
[Time Frame: Day 1]
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Time of maximum observed concentration (tmax) - D1
[Time Frame: Day 1]
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Time of maximum observed concentration (tmax) - D9
[Time Frame: Day 9]
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Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D1
[Time Frame: Day 1]
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Area under the plasma concentration time curve extrapolated to infinity (AUC0-8) - D9
[Time Frame: Day 9]
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Maximum observed plasma concentration (Cmax) - D1
[Time Frame: Day 1]
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Maximum observed plasma concentration (Cmax) - D9
[Time Frame: Day 9]
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Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D9
[Time Frame: Day 9]
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Secondary ID(s)
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BIA-3202-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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